Antiseptic tampon and method of preparing it

ABSTRACT

The invention relates to an antiseptic tampon and a method of preparing it, which method consists of introducing metered quantities of a liquid mixture of antiseptic product and hydrophobic excipient into individual sheaths ( 14 ) for packaging tampons, then introducing standard tampons ( 22 ) into said sheaths ( 14 ) so that their lower ends are immersed in the mixture of antiseptic product and excipient, and then closing and sealing said sheaths ( 14 ).

REFERENCE TO RELATED APPLICATION

[0001] This application is a continuation of the PCT InternationalApplication No. PCT/FR00/03681 filed Dec. 26, 2000, which is based onthe French Application No. 99-16847 filed Dec. 29, 1999.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] The invention relates to an antiseptic tampon and a method ofpreparing it.

[0004] 2. Description of the Prior Art

[0005] A standard tampon is known to constitute a focus of potentialinfection of the vagina because its insertion can be accompanied by theintroduction of more or less pathogenic bacteria present in the vulvaand on the surrounding skin surface. The tampon is made from anabsorbent material and tends to dry the mucous membranes of the vagina,which makes them fragile and more sensitive to various infections.

[0006] To reduce this inconvenience it has been proposed to make tamponsfrom a less absorbent material, although they then have to be changedmore frequently, for example every four hours, which is highlyinconvenient and a great nuisance.

[0007] A tampon has also been proposed, in particular in the documentEP-A-0 110 793, which has a cup-shaped cell at one end and a pessarycontaining an antiseptic or medication and fixed into the cell by asoluble adhesive gum. When the tampon is inserted, the pessary is in thevicinity of the neck of the uterus and renders aseptic the vagina andthe blood flowing into the vagina.

[0008] The above tampon is difficult to mass produce economically, inparticular because of the cell formed at the end of the tampon, theapplication of a soluble adhesive gum and the placing of a pessary ofantiseptic or medication in the cell.

OBJECTS OF THE INVENTION

[0009] The object aims particularly to provide a simple, effective andeconomic solution to the problems cited above.

[0010] An object of this invention is an aseptic tampon which avoids therisks of infection of the vagina without making the mucous membranes ofthe vagina fragile.

[0011] Also an object of this invention is an antiseptic tampon which isprepared from a standard tampon.

[0012] A further object of this invention is a method of preparing anantiseptic tampon which is economical and which lends itself toautomatic mass production on machines of a type known in the art.

SUMMARY OF THE INVENTION

[0013] Accordingly, the invention proposes a method of preparing atampon made from an absorbent material and containing an antisepticproduct, characterized in that it consists of introducing meteredquantities of a liquid mixture of antiseptic product and hydrophobicexcipient into individual tampon packaging sheaths, then introducingtampons into said sheaths so that their ends intended to be covered withsaid mixture are at the bottom of said sheaths and in contact with themixture, and closing and sealing said sheaths.

[0014] Thus tampons in accordance with the invention are preparedconcomitantly with packaging them, in a particularly simple and economicmanner.

[0015] According to another further characteristic of the invention,this method also consists of preparing the mixture of antiseptic productand excipient by heating the excipient to melt it, adding the antisepticproduct to the molten excipient and mixing the antiseptic product andthe excipient before pouring the mixture into the packaging sheaths, andthen solidifying the mixture of antiseptic product and excipient on thetampons by cooling after closing the sheaths.

[0016] This produces a lubricating, hydrophobic, antiseptic and strongcovering of the end of the tampon which is inserted into the vaginafirst.

[0017] Advantageously, the method according to the invention alsoconsists of thermoforming semicylindrical cells in two strips ofplastics material, for example PVC, the cells opening onto a lateraledge of said strips, applying the two strips face-to-face to form saidsheaths by joining two facing cells, and heat-welding the two stripstogether.

[0018] A method of the above kind can be executed on machines of a typeknown in the art, used in particular to manufacture suppositories, andtherefore requires a small investment in hardware, since it issufficient to adapt existing machines.

[0019] According to another feature of the invention, Döderlein'sbacillus (lactobacillus casei) is added to the mixture of the excipientand the antiseptic product before they are poured into the packaging ofthe tampons, for example in freeze-dried form and at a rate of the orderof 90 mg per tampon.

[0020] The tampons prepared in the above way are intended to be used atthe end of a menstrual period, to re-seed the flora normally present inthe vagina.

[0021] The invention also proposes an antiseptic tampon, prepared by themethod above-described, characterized in that the mixture of theantiseptic product and the hydrophobic excipient forms a covering of anend portion of the tampon.

[0022] This mixture of antiseptic product and hydrophobic excipientcovers the end part of the tampon in the vicinity of the neck of theuterus when the tampon is in place and prevents all risk of drying themucous membranes of the vagina or making them fragile, with anadditional antiseptic effect which protects the vagina from the risks ofinfection.

[0023] The hydrophobic excipient is advantageously a lubricant whichfacilitates inserting the tampon and avoids the need to use anapplicator.

[0024] In a preferred embodiment of the invention, the antisepticproduct is nonoxynol 9.

[0025] The above product has been used for more than thirty years as aspermicide in many preparations for vaginal application and its goodlocal and general tolerance have been proven by many studies.

[0026] According to another feature of the invention, this antiseptictampon is prepared from a standard tampon.

[0027] This feature greatly reduces the unit cost of the tamponaccording to the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The invention will be better understood and other features,details and advantages of the invention will become more clearlyapparent after reading the following description, which is given by wayof example and with reference to the accompanying drawings, in which:

[0029]FIG. 1 is a diagram showing essential steps of a method accordingto the invention;

[0030]FIG. 2 is a diagrammatic view of a tampon in accordance with theinvention inside its individual packaging.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0031] In the method shown in FIG. 1, the first step consists of payingout two strips 10 of a heat-sealable plastics material, such aspolyvinyl chloride, for example, and thermoforming semicylindrical cells12 in each of the strips, the cells opening at one end onto a lateraledge of the corresponding strip 10, whereas their other end is at adistance from the other lateral edge of the strip 10.

[0032] The two strips 10 are then moved towards each other and pressedtogether with their semicylindrical cells 12 substantially vertical andfacing each other to form cylindrical sheaths 14 open at the top.

[0033] The two strips 10 are fixed together to form a single stripexcept in a lateral area 16 in which the two strips 10 remain separatefrom each other, this lateral area 16 extending along the lateral edgeof the strips 10 on the same side as the bottoms of the sheaths 14.

[0034] In a preferred embodiment of the invention, the two strips 10 areheat-welded together at a temperature of approximately 200° C.

[0035] The next step of the method consists of pouring into each sheath14 a metered quantity of a liquid mixture containing an antisepticproduct and a hydrophobic and lubricating excipient.

[0036] The mixture is prepared by melting the excipient, which isadvantageously based on glycerides, for example the product SUPPOCIRE AMsold by GATTEFOSSE. The product is placed in a tank 18 withthermostatically controlled heating walls. This tank is heated to atemperature of approximately 50-55° C., for example, and a quantity ofexcipient is then placed in it, for example approximately 60 kg; theexcipient is then maintained in the molten state in the tank at atemperature in the order of 38° C. The tank 18 is equipped with apaddle-blade stirrer for mixing the excipient in the tank until it hasall melted.

[0037] A predetermined quantity of an antiseptic product is then addedto the tank, preferably nonoxynol 9, which is an anhydrous viscousliquid, principally composed of polyethylene glycol monononylphenylethers, with the general formula C9H19C6H4—(OCH2—CH2)n-OH, where n isgenerally equal to 9 but can be from 6 to 16.

[0038] 5 kg of nonoxynol 9 and 65 kg of excipient are placed in the tank18, for example, and mixed for approximately 30 minutes at 38° C. toobtain a homogeneous mixture.

[0039] The tank 18 is connected to metering apparatus 20 of a type knownin the art for pouring the mixture of antiseptic product and excipientinto the sheaths 14, at a rate of 700 mg per sheath, for example, tofill the lower ends of the sheaths.

[0040] Standard tampons 22 are then inserted into the sheaths 14, forexample manually or by means of an automatic feed system 24, so that therounded end 26 of the tampon is immersed in the mixture contained in thebottom of the sheath 14.

[0041] The standard tampon 22 is made from natural fibers (viscoseand/or cotton) contained in a soft web of a non-woven textile materialand possibly includes an extraction cord 28 made from a hydrophobicmaterial.

[0042] The sheaths 14 containing the tampons 22 then move to a sealingand marking station 30 in which the upper end 32 of each sheath 14 issealed and printed with a batch number and an expiry date.

[0043] The sheaths 14 then enter a tunnel in which they are cooled toroom temperature, at which the mixture of antiseptic product andexcipient covering the lower end portion of each tampon 22 solidifies.

[0044] Pre-cut transverse lines 24 are formed in the strips 10 betweenthe sheaths 14.

[0045] Cutting means 36 then cut the strips 10 into cards containing apredetermined number of tampons packaged in the sheaths 14. The cardscan themselves be packaged in cardboard cartons on which thecorresponding batch numbers and expiry dates are printed.

[0046]FIG. 2 is a diagram showing to a larger scale a tampon accordingto the invention in its individual packaging sheath 14.

[0047] The lower end 26 of the tampon 22 has a solid covering consistingof the mixture of the antiseptic product and the hydrophobic andlubricating excipient and the lower end of the sheath 14 is extended bytwo independent flaps formed by the parts of the strips 10 in the freearea 16 between two transverse cuts 34, enabling the sheath to be openedeasily by pulling on these two flaps.

[0048] The quantity of antiseptic product that each tampon includes canobviously be varied to some degree. It is less than approximately 150 mgand preferably of the order of 50 mg in the case of nonoxynol 9.Similarly, the quantity of hydrophobic and lubricating excipient canvary about the value of 650 mg per tampon, for example fromapproximately 500 to 800 mg.

[0049] The preparation of tampons in accordance with the invention,which uses standard tampons and existing machines for manufacturingsuppositories, is highly economical and requires a relatively smallinvestment.

[0050] The antiseptic product and the hydrophobic and lubricatingexcipient used are very well tolerated and have virtually nocontra-indications, with the result that the tampon according to theinvention does not cause any irritation of the mucous membranes of thevagina, and tests have shown that it can be classified as a materialthat is not sensitized by contact with the skin.

[0051] Repeated use of the tampon reduces and prevents the risks ofinfection and strengthens the protection of the mucous membranes of thevagina.

[0052] The tampon according to the invention can also be used at the endof a menstrual period to reseed the flora normally present in thevagina. To this end, Doderlein's bacillus (Bacillus casei) is added tothe mixture of the antiseptic product and the excipient poured into thepackaging sheaths 14. Doderlein's bacillus is available in freeze-driedform and is metered at a rate of the order of 80 to 120 mg per tampon,preferably approximately 90 mg.

1. A method of preparing tampons made from an absorbent material andcontaining an antiseptic product, comprising the following steps of:introducing metered quantities of a liquid mixture of said antisepticproduct and a hydrophobic excipient into individual tampon packagingsheaths, then introducing said tampons into said sheaths so that ends ofsaid tampons intended to be covered with said mixture are at the bottomof said sheaths and in contact with said mixture, and closing andsealing said sheaths.
 2. A method according to claim 1, furthercomprising a step of preparing said mixture of antiseptic product andhydrophobic excipient by heat-melting said excipient, by adding saidantiseptic product to the molten excipient and by mixing said antisepticproduct and said molten excipient before pouring said mixture into saidsheaths, and then by solidifying said mixture on said tampons by coolingafter closing said sheaths.
 3. A method according to claim 1, comprisinga step of adding Dbderlein's bacillus to said mixture of antisepticproduct and hydrophobic excipient, before pouring said mixture into saidsheaths.
 4. A method according to claim 1, further comprising the stepsof thermoforming semicylindrical cells in two strips of plasticsmaterial, said cells opening onto a lateral edge of said strips,applying said two strips face-to-face to form said sheaths by joiningtwo facing semi-cylindrical cells, and heat-welding said stripstogether.
 5. An antiseptic tampon made from an absorbent material andhaving an end portion covered by a mixture of an antiseptic product andan hydrophobic excipient.
 6. A tampon according to claim 5, wherein saidantiseptic product is nonoxynol
 9. 7. A tampon according to claim 5,wherein said hydrophobic excipient is a lubricant and is based onglycerides.
 8. A tampon according to claim 5, wherein said mixturecontains a quantity of said antiseptic product less than toapproximately 150 mg.
 9. A tampon according to claim 5, wherein saidmixture contains approximately 500 to 800 mg of said hydrophobicexcipient.
 10. A tampon according to claim 5, individually packaged in asealed sheath of plastics material.
 11. A tampon according to claim 5,prepared from a standard tampon.
 12. A tampon according to claim 5,wherein said mixture covering of said end portion contains Doderlein'sbacillus and said tampon is intended to be used at the end of amenstrual period.